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LB-005 Hemera 1 carboxyhemoglobin oxygendelivery for revascularization in acute stroke: a prospective, randomized phase 1 clinical trial
  1. I Linfante1,
  2. W Clark2,
  3. D Houssen3,
  4. R Hanel4,
  5. R Reshi5,
  6. G Dabus6,
  7. R Jubin7,
  8. T Nguyen8,
  9. J Grotta9,
  10. R Wicks1,
  11. M Pervez1,
  12. M Cipolla10,
  13. D Liebeskind11,
  14. R Nogueira12
  1. 1Miami Neuroscience Institute, Baptist Health Miami, Miami, FL
  2. 2Radiology, Oregon Health and State University (OHSU) Medical Center, Portland, OR
  3. 3Neurology, Interventional NeuroRadiology, Grady Hospital Emory University, Atlanta, GA
  4. 4Neurosurgery, Baptist Health Miami, Jacksonville, FL
  5. 5Neurology, University of Okhlahoma, Oklahoma City, OK
  6. 6Miami Neuroscience Institute, Baptist Health S Florida, Miami, FL
  7. 7Prolong Pharmaceuticals, South Plainfield, NJ
  8. 8Neurology and Interventional Neuroradiology, Boston University, Boston, MA
  9. 9Neurology, University of Texas, Houston, Houston, TX
  10. 10University of Vermont, Burlington, VT
  11. 11Neuology, University of Callifornia Los Angeles, Los Angeles, CA
  12. 12University of Pittsburg Medical Center, Pittsburg, PA


Background PP-007 is a PEGylated bovine carboxyhemoglobin gas transfer molecule with pleotropic cytoprotective effects, vasodilatation, plasma expansion and optimization of oxygen delivery. Rodent middle cerebral artery occlusion models have demonstrated that PP-007 increases blood flow in the collateral circulation and reduces final infarct volumes, supporting a potential role as neuroprotective agent in acute ischemic stroke. We aim to evaluate the safety and feasibility of PP-007 as an adjunctive treatment to mechanical thrombectomy (MT) in patients with stroke secondary to large vessel occlusion (LVO).

Methods HEMERA-1 was a multicenter, prospective, randomized, controlled phase 1 clinical trial. Anterior circulation LVO patients were assigned in a 3:1 ratio to receive either PP-007 (320mg/kg: 30 minutes bolus followed by 2-hour infusion) plus MT or MT alone within 24 hours after symptom onset. Other key inclusion criteria were baseline NIHSS ≥6, baseline Alberta Stroke Program Early CT Score (ASPECTS) ≥5 and/or estimated core volumes ≤70mL with mismatch >50mL on CT perfusion, pre-morbid modified Rankin Scale <2, and ineligibility for intravenous thrombolysis. The primary endpoint comprised a comprehensive safety evaluation by a Data Monitoring Safety Board.

Results A total of 17 patients were recruited. The mean ± SD age, baseline NIHSS, and ASPECTS were 74.8±12.7 years, 17.3±4.2, and 7.9±1.8, respectively. Twelve patients were randomized PP-007 plus MT, 1 was randomized but not treated, 4 patients were randomized to MT alone. Recanalization of the occluded vessel was achieved in all patients. Seven PP-007 patients in 2 centers had temporary elevation of Partial Prothrombin Time most likely artifactual without any clinical consequences. A transient systolic blood pressure increase (20-40 mmHg) during the bolus was observed in all PP-007 patients without any clinical consequences. There were no other safety concerns.

Conclusion No significant safety concerns were identified for the adjunctive use of PP-007in patients undergoing MT ( NCT04677777).

Disclosures I. Linfante: 2; C; Penumbra, Stryker, Q’Appel, Cerenovus. 3; C; Penumbra, Stryker, Q’Appel, Cerenovus. 4; C; Prolong Pharmaceuticals, InNeuroCo,Three Rivers, InNeuroFine, Deinde. W. Clark: None. D. Houssen: None. R. Hanel: None. R. Reshi: None. G. Dabus: 4; C; three rivers, InNeuroCo, synchron. R. Jubin: 5; C; Prolong Pharmaceuticals. T. Nguyen: None. J. Grotta: None. R. Wicks: None. M. Pervez: None. M. Cipolla: None. D. Liebeskind: None. R. Nogueira: None.

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